Study to Evaluate the Safety of ALLO-ASC-DFU in the Subjects With Dystrophic Epidermolysis Bullosa

August 23, 2023 updated by: Anterogen Co., Ltd.

A Phase 1/2 Clinical Study to Evaluate the Safety of ALLO-ASC-DFU in the Subjects With Dystrophic Epidermolysis Bullosa

This is a phase I/II open-label study to evaluate the efficacy and safety of ALLO-ASC-DFU in patients with Dystrophic Epidermolysis Bullosa.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

ALLO-ASC-DFU is a hydrogel sheet containing allogenic adipose-derived mesenchymal stem cells. Adipose-derived stem cells have anti-inflammatory effect and release growth factors such as vascular endothelial growth factor (VEGF) and hepatocyte growth factor (HGF), which can enhance wound healing and regeneration of new tissue, finally may provide an new option in treating a Dystrophic Epidermolysis Bullosa.

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age : 10~60
  2. Diagnosed with Dystrophic Epidermolysis Bullosa based on immunofluorescence test.
  3. Bullous skin lesion sized over 10 cm^2
  4. Test negative for Serum β-HCG pregnancy test on screening, if the subject is fertile
  5. A subject who is willing to follow the protocol and provide a informed consent on screening, given that the information with respect to the clinical trial is provided.

Exclusion Criteria:

  1. A subject with history of epidermoid carcinoma within a year from screening.
  2. A subject who requires antibiotics due to bacterial infection on skin.
  3. A subject who was dosed with oral steroid, over 0.5mg/kg a day for subjects under 18, or over 20mg in 2 weeks for subjects over 18, within 30 days prior to screening.
  4. A subject treated with radiotherapy or immunosuppressants, within 30 days prior to screening.
  5. A subject treated with steroids locally, within 30 days prior to screening.
  6. A subject with 2-times the maximum-standardized value of ALT, AST, ALP, bilirubin, total protein
  7. A subject with 2-times the maximum-standardized value of BUN, Creatinine
  8. A subject with Albumin below 2.0 g/dL.
  9. A subject with Hemoglobin below 6 g/dL (anemic).
  10. A subject with allergic response to bovine derived protein and fibrin glue.
  11. A subject administered with biologic agents or cell therapy, within 30 days prior to screening.
  12. A subject administered with stem cell treatment by IV or subcutaneously to the target wound, prior to the trial
  13. A subject who enrolled into another clinical trial, within 30 days prior to screening
  14. A subject with serious disease that can affect on clinical trial.
  15. A pregnant or breast-feeding subject.
  16. A subject with history of drug abuse within 1 year of clinical significance
  17. A subject who cannot proceed according to the protocol.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ALLO-ASC-DFU
Other: Allogeneic mesenchymal stem cells
Dressing for Dystrophic Epidermolysis Bullosa wound.
Other Names:
  • ALLO-ASC-DFU
Active Comparator: Conventional Therapy
Device: Polyurethene Film
Dressing for Dystrophic Epidermolysis Bullosa wound.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Area of re-epithelization
Time Frame: Follow up to 8 weeks
Follow up to 8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of a target wound's re-epithelialization
Time Frame: Every time of visit for follow up to 8 weeks
Every time of visit for follow up to 8 weeks
Time taken to re-epithelization
Time Frame: Over 8 weeks
Over 8 weeks
Safety assessed by clinically measured abnormality of laboratory tests and adverse events
Time Frame: Over 8 weeks
Over 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anterogen Co., Ltd.

Investigators

  • Principal Investigator: Su Chan Kim, PhD., Gangnam Severence Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 8, 2015

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

April 30, 2023

Study Registration Dates

First Submitted

October 16, 2015

First Submitted That Met QC Criteria

October 16, 2015

First Posted (Estimated)

October 19, 2015

Study Record Updates

Last Update Posted (Actual)

August 25, 2023

Last Update Submitted That Met QC Criteria

August 23, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALLO-ASC-EB-101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Dystrophic Epidermolysis Bullosa

Clinical Trials on Allogeneic mesenchymal stem cells

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Portugal

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe